A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss

Summary

The purpose of this study is to determine whether a high-quality proteinfood supplement
will help HIV-positive patients maintain, and possibly gain, muscle mass.

Many HIV-positive patients lose weight that they are then unable to regain. This may be
because patients are not eating enough protein or are not eating the right kinds of protein.
The protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the
amount of protein lost due to HIV infection. This study gives patients high-quality protein
food supplements to help them maintain and/or gain weight.

Description

In many HIV-infected individuals with prior weight loss, the failure to regain weight and
lean tissue is at least in part the consequence of inadequate protein intake or ingestion of
a poor-quality protein rather than total caloric intake. Dietary sources of protein are
presumably inadequate to meet the high metabolic needs caused by HIV infection. To achieve a
target protein intake in the range (1.5 to 2.0 g/kg/day) demonstrated in other catabolic
diseases necessary to achieve positive nitrogen balance and to generate substantial anabolic
effects, this study will administer a supplement containing high-quality protein.

Two groups of 28 patients each are randomly chosen to receive either an oral nutritional
supplement (Optimune) containing increased amounts of high-quality protein (whey), which is
rich in cysteine and glutamine, or an isocaloric, identical-tasting supplement without added
whey protein or amino acid supplementation. Weight, body composition, anthropometry, dietary
intake, and general physical health are assessed at baseline and at Weeks 6 and 12. Plasma
cysteine, glutathione, C-reactive protein, and prealbumin, along with urine IL-6, sTNFrII,
and IL-1ra, are assessed at baseline and at Week 12.

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Medical and Biotech [MESH] Definitions

Spirulina

A genus of filamentous CYANOBACTERIA found in most lakes and ponds. It has been used as a nutritional supplement particularly due to its high protein content.

Halitosis

An offensive, foul breath odor resulting from a variety of causes such as poor oral hygiene, dental or oral infections, or the ingestion of certain foods.

The study of NUTRITION PROCESSES during EXERCISE and ATHLETIC PERFORMANCE as well as specific NUTRITIONAL REQUIREMENTS of ATHLETES and the relationship between NUTRITIONAL STATUS and NUTRITION DISORDERS in athletes.

Soft Tissue Infections

Infections of non-skeletal tissue, i.e., exclusive of bone, ligaments, cartilage, and fibrous tissue. The concept is usually referred to as skin and soft tissue infections and usually subcutaneous and muscle tissue are involved. The predisposing factors in anaerobic infections are trauma, ischemia, and surgery. The organisms often derive from the fecal or oral flora, particularly in wounds associated with intestinal surgery, decubitus ulcer, and human bites. (From Cecil Textbook of Medicine, 19th ed, p1688)

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Human Immuno Deficiency Virus (HIV)Human Immunodeficiency Virus (HIV), the causative agent of AIDS.
The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...